High Risk Cardiovascular Disease study: Zilebesiran
Official title Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
ClinicalTrials.gov ID: NCT07181109
What this study is testing
What is Zilebesiran?
An investigational subcutaneous injectable medicine being studied to lower the risk of cardiovascular death, heart attack, stroke, or heart‑failure events in people with high‑risk cardiovascular disease. It is designed to silence the gene that makes angiotensinogen, reducing the activity of the renin‑angiotensin system that contributes to high blood pressure and heart stress.
Also referred to as ALN-AGT01.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether zilebesiran (a medicine) reduces the risk of heart death, heart attack, stroke, or heart failure.
- Who it's for
- You may be able to join if you have high blood pressure that is not well controlled and you have heart disease or a high risk for it.
- What's involved
- You would take zilebesiran or a pretend pill. You will have regular check‑ups to see if any heart problems happen.
- Time commitment
- The study continues until enough heart events occur; you will attend scheduled visits over several years.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Is 18 years or older for patients with established cardiovascular disease (CVD)
- Is 55 years or older for patients with high risk for CVD
- Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD
- Has treated hypertension on stable therapy with at least 2 standard of care antihypertensive medications, one of which must be a thiazide...
You likely can't join if
- Has known history of secondary hypertension
- Has symptomatic orthostatic hypotension
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3×upper limit of normal (ULN)
- Has total serum bilirubin \>1.5×ULN
- Has international normalized ratio (INR) \>1.5
- Has serum potassium \>4.8 mEq/L
See the full eligibility criteria
- Is 18 years or older for patients with established cardiovascular disease (CVD)
- Is 55 years or older for patients with high risk for CVD
- Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD
- Has treated hypertension on stable therapy with at least 2 standard of care antihypertensive medications, one of which must be a thiazide, thiazide-like, or loop diuretic
- Has known history of secondary hypertension
- Has symptomatic orthostatic hypotension
- Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3×upper limit of normal (ULN)
- Has total serum bilirubin \>1.5×ULN
- Has international normalized ratio (INR) \>1.5
- Has serum potassium \>4.8 mEq/L
- Has estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m\^2
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Fairhope, Alabama, United States
- Foley, Alabama, United States
- Huntsville, Alabama, United States
- Sheffield, Alabama, United States
- Chandler, Arizona, United States
- Gilbert, Arizona, United States
- Mesa, Arizona, United States
- Phoenix, Arizona, United States
- Sun City, Arizona, United States
- Sun City West, Arizona, United States
- Tempe, Arizona, United States
- Tucson, Arizona, United States
- Yuma, Arizona, United States
- Little Rock, Arkansas, United States
- Beverly Hills, California, United States
- Chula Vista, California, United States
- Covina, California, United States
- Escondido, California, United States
- Glendale, California, United States
+ 801 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Fairhope, Alabama, United States; Foley, Alabama, United States; Huntsville, Alabama, United States; Sheffield, Alabama, United States; Chandler, Arizona, United States and 815 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.